This month, Mutual Pharmaceutical Company is appealing to the Supreme Court the ruling of a lower court that awarded a New Hampshire woman $21 million in damages for a severe reaction to a generic drug.
The drug, a prescription painkiller, caused an extremely serious skin reaction in 53-year-old Karen Bartlett, from Plaistow, N.H.
The reaction, called toxic epidermal necrolysis, is a severe form of Stevens-Johnson Syndrome. The syndrome is an unusual reaction to a drug and is characterized by the sloughing off of skin. In Bartlett’s case, she lost two-thirds of her skin over a period of months and had to be treated in a hospital burn unit. She was put into a medically induced coma for a number of months, suffered damage to her lungs and esophagus, and became legally blind, for which she had 13 operations.
Bartlett’s lawyers argued that the drug’s design was defective. The drug maker, Mutual Pharmaceutical, appealed but lost the decision. Mutual had argued that the design of the drug, by law, had to be the same as the drug it was mimicking. But the Court rejected that argument, saying that Mutual was not obligated to sell the defective generic drug and could have pulled it from the market.
Mutual is now appealing the lower court’s decision to the U.S. Supreme Court. The company is arguing that the decision could discourage drug makers from bringing valuable new drugs to market or withdraw others that help many patients. It also is contending that juries might be able to overrule a drug’s approval by the U.S. Food and Drug Administration (FDA) and undermine its expertise and authority.
On the other side, trial lawyers caution that few options will be left to persons injured by drugs.
In both instances, the generic drug maker has to abide by the law that says that the drug design and label must be the same as those of the original drug’s maker.
Generic drug makers, trial lawyers, consumer advocates and others are eagerly looking forward to the Court’s decision.
For more information or to speak with a defective drug lawyer about a potential side effects claim, contact Flood Law Group today.